510(k) · Cleared
ClearedVnus Radiofrequency Generator, Model RFG2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vnus Medical Technologies, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jun 7, 2004 as substantially equivalent to K982816 (Vnus Medical Technologies, Inc., 1999) and 2 other predicates after an 89-day review. Its family tree reaches back 8 generations to 1995. 10 later devices descend from it.
- Decided
- Jun 7, 2004
- Review
- 89 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K943450 (1995). 23 ancestors in all, the oldest K800617 (1980). 10 later devices descend from it, 5 citing it directly.
- Root · 8 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 7 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 6 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 5 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 4 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 3 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 2 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 1 generation backK030557 Modification to Vnus Closure SystemVnus Medical Technologies, Inc. · 2003
- This deviceK040638 Vnus Radiofrequency Generator, Model RFG2Vnus Medical Technologies, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK160754 Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)Venclose, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 2 of its ownK211806 Venclose digiRF Generator with Maven Catheter, Venclose Maven…Venclose, Inc. · 2021 · Recalled
- Descendant · cites it directly · 2 of its ownK141858 Closurerfg Radiofrequency GeneratorCovidien · 2014
- Descendant · 2 generations on · 1 of its ownK250068 Venclose digiRF Generator (VCRFG1)Venclose, Inc. · 2025 · Recalled
- Descendant · 2 generations on · 0 of its ownK253918 Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)F Care Systems USA, LLC · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K160754Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)Venclose, Inc. · 2016 · cites it directly3descendants
- K211806Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF…Venclose, Inc. · 2021 · 2 generations on2descendants
- K141858Closurerfg Radiofrequency GeneratorCovidien · 2014 · cites it directly2descendants
- K250068Venclose digiRF Generator (VCRFG1)Venclose, Inc. · 2025 · 2 generations on1descendant
- K253918Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)F Care Systems USA, LLC · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −7 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −6 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −5 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −4 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −3 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −2 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −1 | K030557 | Modification to Vnus Closure System | Vnus Medical Technologies, Inc. | 2003 | — |
| 0 (this device) | K040638 | Vnus Radiofrequency Generator, Model RFG2 | Vnus Medical Technologies, Inc. | 2004 | — |
| +1 | K160754 | Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) | Venclose, Inc. | 2016 | 2 |
| +2 | K211806 | Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose… | Venclose, Inc. | 2021 | 1 |
| +1 | K141858 | Closurerfg Radiofrequency Generator | Covidien | 2014 | — |
| +2 | K250068 | Venclose digiRF Generator (VCRFG1) | Venclose, Inc. | 2025 | 1 |
| +2 | K253918 | Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) | F Care Systems USA, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 6 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K982816 | Vnus Closure SystemSummary page 1…® VNUS RF Generator models RF-1 10 and RF-220 cleared as a part of the VNUS® Coagulation System (K982816, K003092, and K030557), and VNUS Vessel and Tissue System (K0033547) Device Description:… | 1999 |
| * | K003092 | Modification to Vnus Closure SystemSummary page 1…F Generator models RF-1 10 and RF-220 cleared as a part of the VNUS® Coagulation System (K982816, K003092, and K030557), and VNUS Vessel and Tissue System (K0033547) Device Description:… | 2000 |
| * | K030557 | Modification to Vnus Closure SystemSummary page 1…odels RF-1 10 and RF-220 cleared as a part of the VNUS® Coagulation System (K982816, K003092, and K030557), and VNUS Vessel and Tissue System (K0033547) Device Description:… | 2003 |
| Kept off the family tree | K003354 | VNUS Vessel and Tissue System Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…the VNUS® Coagulation System (K982816, K003092, and K030557), and VNUS Vessel and Tissue System (K0033547) Device Description: electronic, The VNUS… |
What descends from it? (10)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160754 | Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) | 2016 | 3 |
| K141858 | Closurerfg Radiofrequency Generator | 2014 | 2 |
| K232505 | Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter | 2024 | 0 |
| K222997 | VVR Generator system | 2023 | 0 |
| K160639 | Electrosurgical Generator ESG-200 | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 23 ancestors has a recall of any class.
- Of its descendants, K160754 (Venclose, Inc., 2016) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K982816.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The VNUS Radiofrequency Generator is intended for use with VNUS radiofrequency devices intended for vessel and tissue coagulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040638 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040638: Vnus Radiofrequency Generator, Model RFG2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040638
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026